,i #aafth ,,congress #b;d ,session ,h4 ,r4 #gebg ,,in ,,the ,,house ,,of ,,representatives ,july #i1 #bjbj,miss ,gonzlez-,coln of ,puerto ,rico 7for herself1 ,mr4 ,serrano1 ,mr4 ,bishop of ,utah1 ,ms4 ,shalala1 ,mr4 ,king of ,new ,york1 and ,mr4 ,soto7 introduced the following bill2 which was referred to the ,committee on ,ways and ,means1 and in addition to the ,committee on ,energy and ,commerce1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to rescue domestic medical manufacturing activity by providing incentives in economically distressed areas of the ,united ,states and its possessions4 #a4 ,short title ,this ,act may be cited as the ,medical ,manufacturing1 ,economic ,development1 and ,sustainability ,act of #bjbj or the ,,mmeds ,act of #bjbj4 #b4 ,economically distressed zones 7a7 ,in general ,chapter #a of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new subchapter3 ,,aa ,medical ,manufacturing in ,economically ,distressed ,zones ,subchapter ,,aa--,medical ,manufacturing in ,economically ,distressed ,zones ,sec4 #adjj;,,aa-#a4 ,medical manufacturing in economically distressed zone credit4 ,sec4 #adjj;,,aa-#b4 ,credit for economically distressed zone products and services acquired by domestic medical manufacturers4 ,sec4 #adjj;,,aa-#c4 ,special rules to secure the national supply chain and for the production of population health products4 ,sec4 #adjj;,,aa-#d4 ,designation of economically distressed zones4 #adjj;,,aa-#a4 ,medical manufacturing in economically distressed zone credit 7a7 ,allowance of credit ,there shall be allowed as a credit against the tax imposed by subtitle ,a for the taxable year an amount equal #dj percent of the sum of-- 7#a7 the aggregate amount of the taxpayer's medical manufacturing economically distressed zone wages for such taxable year1 7#b7 the allocable employee fringe benefit expenses of the taxpayer for such taxable year1 and 7#c7 the depreciation and amortization allowances of the taxpayer for the taxable year with respect to qualified medical manufacturing facility property4 7b7 ,denial of double benefit ,any wages or other expenses taken into account in determining the credit under this section may not be taken into account in determining the credit under sections #da1 and any other provision determined by the ,secretary to be substantially similar4 7c7 ,definitions and special rules ,for purposes of this section-- 7#a7 ,economically distressed zone wages 7,a7 ,in general ,the term economically distressed zone wages means amounts paid or incurred for wages of an employee by the taxpayer for the taxable year which are-- 7i7 in connection with the active conduct of a trade or business of the taxpayer1 and 7ii7 the principal place of employment of whom is in a qualified medical manufacturing facility of such taxpayer4 7,b7 ,limitation on amount of wages taken into account 7i7 ,in general ,the amount of wages which may be taken into account under subparagraph 7,a7 with respect to any employee for any taxable year shall not exceed the contribution and benefit base determined under section #bcj of the ,social ,security ,act for the calendar year in which such taxable year begins4 7ii7 ,treatment of part-time employees1 etc ,if-- 7,i7 any employee is not employed by the taxpayer on a substantially full-time basis at all times during the taxable year1 or 7,,ii7 the principal place of employment of any employee is not within an economically distressed zone at all times during the taxable year1 the limitation applicable under clause 7i7 with respect to such employee shall be the appropriate portion 7as determined by the ,secretary7 of the limitation which would otherwise be in effect under clause 7i74 7,c7 ,treatment of certain employees ,the term economically distressed zone wages shall not include any wages paid to employees who are assigned by the employer to perform services for another person1 unless the principal trade or business of the employer is to make employees available for temporary periods to other persons in return for compensation4 7#b7 ,allocable employee fringe benefit expenses 7,a7 ,in general ,the term allocable employee fringe benefit expenses means the aggregate amount allowable as a deduction under this chapter to the taxpayer for the taxable year for the following amounts which are allocable to employment in a qualified medical manufacturing facility3 7i7 ,employer contributions under a stock bonus1 pension1 profit-sharing1 or annuity plan4 7ii7 ,employer-provided coverage under any accident or health plan for employees4 7iii7 ,the cost of life or disability insurance provided to employees4 7,b7 ,allocation ,for purposes of subparagraph 7,a71 an amount shall be treated as allocable to a qualified medical manufacturing facility only if such amount is with respect to employment of an individual for services provided1 and the principal place of employment of whom is1 in such facility4 7#c7 ,qualified medical manufacturing facility ,the term qualified medical manufacturing facility means any facility that-- 7,a7 researches and develops or produces medical products1 and 7,b7 is located within an economically distressed zone4 7#d7 ,qualified medical manufacturing facility property ,the term qualified medical manufacturing facility property means any property used in 7or consisting of7 a qualified medical manufacturing facility if such property is directly connected to the research1 development1 or production of a medical product4 7#e7 ,medical product ,the term medical product means-- 7,a7 any prescription pharmaceutical which-- 7i7 is subject to regulation under-- 7,i7 section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee71 7,,ii7 section #hjb of such ,act 7#ba ,u4,s4,c4 #chb71 or 7,,iii7 section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb71 or 7ii7 is described in section #bja7;jj7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;jj771 or 7,b7 any device 7as that term is defined by section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h777 or part thereof4 7#f7 ,aggregation rules 7,a7 ,in general ,for purposes of this section1 members of an affiliated group shall be treated as a single taxpayer4 7,b7 ,affiliated group ,the term affiliated group means an affiliated group 7as defined in section #aejd7;a71 determined without regard to section #aejd7;b77#c77 one or more members of which are engaged in the active conduct of a trade or business within an economically distressed zone4 #adjj;,,aa-#b4 ,credit for economically distressed zone products and services acquired by domestic medical manufacturers 7a7 ,allowance of credit ,in the case of an eligible medical manufacturer1 there shall be allowed as a credit against the tax imposed by subtitle ,a for the taxable year an amount equal to the applicable percentage of the aggregate amounts paid or incurred by the taxpayer during such taxable year for qualified economically distressed zone products or services4 7b7 ,applicable percentage ,for purposes of this section1 the term applicable percentage means-- 7#a7 #cj percent in the case of amounts paid or incurred to persons not described in paragraph 7#b7 or 7#c71 7#b7 #dj percent in the case of amounts paid or incurred to an unrelated minority business1 and 7#c7 #e percent in the case of amounts paid or incurred to a related person4 7c7 ,eligible medical manufacturer ,for purposes of this section1 the term eligible medical manufacturer means any person in the trade or business of producing medical products in the ,united ,states4 7d7 ,qualified product or service ,for purposes of this section1 the term qualified product or service means-- 7#a7 any product which is produced in an economically distressed zone and which is integrated into a medical product produced by the taxpayer1 and 7#b7 any service which is provided in an economically distressed zone and which is necessary to the production of a medical product by the taxpayer 7including packaging74 7e7 ,minority business ,for purposes of this section-- 7#a7 ,in general ,the term minority business means-- 7,a7 a sole proprietorship carried on by a qualified individual1 or 7,b7 a corporation or partnership-- 7i7 at least #ej percent of the ownership interests in which are held by one or more qualified individuals1 and 7ii7 of which a qualified individual is the president or chief executive officer 7or a substantially equivalent position74 7#b7 ,qualified individual ,the term qualified individual means any individual who-- 7,a7 is of ,asian-,indian1 ,asian-,pacific1 ,black1 ,hispanic1 or ,native ,american origin or descent1 and 7,b7 is a ,united ,states citizen or legal resident of the ,united ,states or any of its territories or possessions4 7f7 ,related persons ,for purposes of this section1 persons shall be treated as related to each other if such persons would be treated as a single employer under the regulations prescribed under section #eb7;b74 7g7 ,other terms ,terms used in this section which are also used in section #adjj;,,aa-#a shall have the same meaning as when used in such section4 #adjj;,,aa-#c4 ,special rules to secure the national supply chain and for the production of population health products 7a7 ,in general ,in the case of a qualified repatriated medical manufacturing facility or a qualified population health product manufacturing facility-- 7#a7 section #adjj;,,aa-#a7;a7 shall be applied by substituting #fj percent for #dj percent1 and 7#b7 section #adjj;,,aa-#b7;a7 shall be applied-- 7,a7 by substituting #ej percent for #cj percent1 and 7,b7 by substituting #fj percent for #dj percent4 7b7 ,election ,to expense in lieu of tax credit for depreciation ,in the case of a taxpayer which elects 7at such time and in such manner as the ,secretary may provide7 the application of this subsection with respect to any qualified repatriated medical manufacturing facility or qualified population health product manufacturing facility-- 7#a7 section #adjj;,,aa-#a7;a77#c7 shall not apply with respect to any qualified medical manufacturing facility property with respect to such facility1 and 7#b7 for purposes of section #afh7k7-- 7,a7 such property shall be treated as qualified property1 and 7,b7 the applicable percentage with respect to such property shall be #ajj percent4 7c7 ,qualified repatriated medical manufacturing facility ,for purposes of this section1 the term qualified repatriated medical manufacturing facility means any qualified medical manufacturing facility 7as defined in section #adjj;,,aa-#a7 the production of which was moved to an economically distressed zone from a foreign country that the ,united ,states ,trade ,representative has determined could pose a risk to the national supply chain because of political or social factors4 7d7 ,qualified population health product manufacturing facility ,for purposes of this section1 the term qualified population health product manufacturing facility means any qualified medical manufacturing facility 7as defined in section #adjj;,,aa-#a7 that produces a population health product 7as defined in section #cai,l7a77#aa7 of the ,public ,health ,service ,act7 which the ,secretary of ,health and ,human ,services has identified for support through a strategic initiative under section #cai,l7c77#d77;,f77ii7 of the ,public ,health ,service ,act4 #adjj;,,aa-#d4 ,designation of economically distressed zones 7a7 ,in general ,for purposes of this subchapter1 the term economically distressed zone means any population census tract within the ,united ,states which-- 7#a7 has a poverty rate of not less than #ce percent for each of the #e most recent calendar years for which information is available1 or 7#b7 satisfies each of the following requirements3 7,a7 has pervasive poverty1 unemployment1 low labor force participation1 and general distress measured as a prolonged period of economic decline measured by real gross national product1 7,b7 has a poverty rate of not less than #cj percent for each of the #e most recent calendar years for which information is available1 and 7,c7 has been designated as such by the ,secretary and the ,secretary of ,commerce pursuant to an application under subsection 7b74 7b7 ,application for designation 7#a7 ,in general ,an application for designation as an economically distressed zone may be filed by a ,state or local government in which the population census tract to which the application applies is located4 7#b7 ,requirements ,such application shall include a strategic plan for accomplishing the purposes of this subchapter1 which-- 7,a7 describes the coordinated economic1 human1 community1 and physical development plan and related activities proposed for the nominated area1 7,b7 describes the process by which the affected community is a full partner in the process of developing and implementing the plan and the extent to which local institutions and organizations have contributed to the planning process1 7,c7 identifies the amount of ,state1 local1 and private resources that will be available in the nominated area and the private_/public partnerships to be used1 which may include participation by1 and cooperation with1 universities1 medical centers1 and other private and public entities1 7,d7 identifies the funding requested under any ,federal program in support of the proposed economic1 human1 community1 and physical development and related activities1 7,e7 identifies baselines1 methods1 and benchmarks for measuring the success of carrying out the strategic plan1 including the extent to which poor persons and families will be empowered to become economically self-sufficient1 and 7,f7 does not include any action to assist any establishment in relocating from one area outside the nominated area to the nominated area1 except that assistance for the expansion of an existing business entity through the establishment of a new branch1 affiliate1 or subsidiary is permitted if-- 7i7 the establishment of the new branch1 affiliate1 or subsidiary will not result in a decrease in employment in the area of original location or in any other area where the existing business entity conducts business operations1 7ii7 there is no reason to believe that the new branch1 affiliate1 or subsidiary is being established with the intention of closing down the operations of the existing business entity in the area of its original location or in any other area where the existing business entity conducts business operation1 and 7iii7 includes such other information as may be required by the ,secretary and the ,secretary of ,commerce4 7c7 ,period for which designations are in effect ,designation as an economically distressed zone may be made at any time during the #aj-year period beginning on the date of the enactment of this section1 and shall remain in effect with respect to such zone during the #ae-year period beginning on the date of such designation4 ,economically distressed zones described in subsection 7a77#a7 shall take effect on the date of the enactment of this ,act and shall remain in effect during the #ae-year period beginning on such date4 7d7 ,territories and possessions ,the term ,united ,states includes the #ej ,states1 the ,district of ,columbia1 and the territories and possessions of the ,united ,states4 7e7 ,regulations ,the ,secretary shall issue such regulations or other guidance as may be necessary or appropriate to carry out the purposes of this section1 including-- 7#a7 not later than #cj days after the date of the enactment of this section1 a list of the population census tracts described in subsection 7a77#a71 and 7#b7 not later than #fj days after the date of the enactment of this section1 regulations or other guidance regarding the designation of population census tracts described in subsection 7a77#b74 4 7b7 ,effective date ,the amendments made by this section shall apply to taxable years beginning after ,december #ca1 #bjai4 #c4 ,authority to support development of population health products 7a7 ,definitions 7#a7 ,qualified countermeasure ,subparagraph 7,a7 of section #cai;,f-#a7;a77#b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#f;a7a77#b77 is amended to read as follows3 7,a7 ,qualified countermeasure ,the term qualified countermeasure means a drug 7as that term is defined by section #bja7;g77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;g77#a7771 biological product 7as that term is defined by section #cea7;i7 of this ,act 7#db ,u4,s4,c4 #bfb7;i7771 or device 7as that term is defined by section #bja7;h7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cba7;h7771 that the ,secretary determines to be a priority consistent with sections #cjb7b7 and #cjd7;a7 of the ,homeland ,security ,act of #bjjb-- 7i7 to diagnose1 mitigate1 prevent1 or treat harm from any biological agent 7including organisms that cause an infectious disease71 toxin1 chemical1 radiological1 or nuclear agent that may cause a public health emergency affecting national security2 or 7ii7 to diagnose1 mitigate1 prevent1 or treat harm from an underlying non-communicable disease which1 combined with pandemic influenza or an emerging infectious disease1 may result in adverse health consequences or serious threat to one or more vulnerable ,american populations 7as defined in section #cai,l7a77 in an epidemic or pandemic4 4 7#b7 ,other definitions ,subsection 7a7 of section #cai,l of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7 is amended by adding at the end the following new paragraphs3 7#aa7 ,population health product ,the term population health product means a widely available drug to diagnose1 mitigate1 prevent1 or treat harm from an underlying non-communicable disease which1 combined with pandemic influenza or an emerging infectious disease1 may result in adverse health consequences or a serious threat to one or more vulnerable ,american populations in an epidemic or pandemic4 7#ab7 ,vulnerable ,american populations ,the term vulnerable ,american populations means children1 pregnant women1 older adults1 minority populations1 and other at-risk individuals with relevant characteristics that warrant consideration during the process of researching and developing such countermeasures and products4 4 7b7 ,strategic initiatives ,clause 7ii7 of section #cai,l7c77#d77;,f7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77#d77;,f77 is amended to read as follows3 7ii7 threats that consistently exist or continually circulate and have a significant potential to become a pandemic1 such as pandemic influenza and emerging infectious diseases in combination with underlying non-communicable diseases1 which may include the advanced research and development1 manufacturing1 and appropriate stockpiling of qualified pandemic or epidemic products1 and products1 technologies1 or processes to support the advanced research and development of such countermeasures 7including multiuse platform technologies for diagnostics1 vaccines1 and therapeutics2 virus seeds2 clinical trial lots2 novel virus strains2 and antigen and adjuvant material72 and 4 7c7 ,at-,risk individuals ,paragraph 7#f7 of section #cai,l7c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77 is amended to read as follows3 7#f7 ,at-risk individuals ,in carrying out the functions under this section1 the ,secretary may give a priority to advanced research and development of-- 7,a7 qualified countermeasures and qualified pandemic or epidemic products likely to be safe and effective with respect to vulnerable ,american populations2 and 7,b7 population health products likely to protect vulnerable ,american populations with underlying non-communicable diseases from disproportionate harm in epidemics and pandemics4 4 7d7 ,other authorities ,section #cai,l7c7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bdg;d-#g;e7c77 is amended by adding at the end the following3 7#h7 ,timely delivery of population health products to at-risk individuals ,the ,secretary shall collaborate with the ,administrator of the ,centers for ,medicare ,medicaid ,services1 the ,secretary of ,defense1 the ,secretary of ,veterans ,affairs1 the ,commissioner of ,food and ,drugs1 and the heads of other ,federal agencies involved with approval and distribution of health products to assure that such ,federal agencies distribute approved population health products as promptly and effectively as possible1 and as continuously as possible1 to protect vulnerable ,american populations from harm in epidemics and pandemics4 7#i7 ,report on need for incentivizing development of population health products ,not later than #ij days after the date of enactment of the ,medical ,manufacturing1 ,economic ,development1 and ,sustainability ,act of #bjbj1 the ,secretary shall examine and report to the ,congress on-- 7,a7 the extent to which the health of aging ,americans1 ,african ,americans1 ,hispanics1 ,native ,americans1 veterans1 or other vulnerable ,american populations has been disproportionately harmed by the ,,covid-#ai pandemic and prior epidemics and pandemics2 7,b7 the population health products currently available and whether there is a need for additional innovation and development to produce population health products to reduce the exposure of vulnerable ,american populations to risk of disproportionate harm in epidemics and pandemics2 and 7,c7 whether the ,secretary recommends providing the same incentives for the development and marketing of population health products as is given with respect to covered infectious disease products under the ,federal ,food1 ,drug1 and ,cosmetic ,act1 including under section #eje;,e of such ,act4 4